Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

Official Title

Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

Brief Summary

      Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm
      (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm.
      Aneurysms that remain pressurized despite EVAR may continue to grow, therefore requiring
      additional surgical interventions. The purpose of this study is to infer the reduction of
      pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to
      assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction
      in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size
      reduction.

Detailed Description

      Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm
      (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm.
      Unfortunately, this procedure is not always successful, and patients need to return to the
      operating room for further procedures because the aneurysm wall remains pressurized and the
      aneurysm continues to grow. Currently, there is no standard non-invasive way of measuring
      aneurysm pressure. The purpose of this study is to infer the reduction of pressure
      transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the
      pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm
      wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction. This is
      clinically relevant because physiologic intraoperative feedback of aneurysm pressure may
      potentially influence surgical decision making in the future, reducing unnecessary
      re-interventions. This will also improve our understanding of the intraoperative physiologic
      response to EVAR.

      Our primary research question is in patients receiving elective endovascular repair of
      abdominal aortic aneurysms (EVAR), does the change in intraoperative ultrasound estimated
      aneurysm wall pressure during EVAR correlate with aneurysm sac size reduction 1 year after
      surgery? Secondary objectives are to assess correlation between intraoperative ultrasound
      estimated aneurysm wall pressure and endovascular leaks and aneurysm-related
      re-interventions.

      A prospective, observational, assessor-blinded and surgeon-blinded study will be conducted at
      the TOH Civic Campus in Ottawa, ON in order to satisfy the objectives of the study.

Study Type

Observational

Primary Outcome

Fractional aneurysm sac size reduction 1 year after surgery

Secondary Outcome

 Fractional aneurysm sac size reduction 30 days after surgery

Condition

Abdominal Aortic Aneurysm

Intervention

Abdominal Aortic Aneurysm Sac Pulsatility

Study Arms / Comparison Groups

 EVAR Patients
Description:  Patients with infrarenal abdominal aortic aneurysm scheduled for elective endovascular aneurysm repair (EVAR) surgery will undergo intraoperative assessments of aneurysm wall pulsatility using ultrasound M-Mode.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

20

Start Date

August 9, 2019

Completion Date

December 9, 2020

Primary Completion Date

December 9, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Elective endovascular aneurysm repair (EVAR) surgery

          -  Infrarenal abdominal aortic aneurysm

          -  Age greater than 18 years old

        Exclusion Criteria:

          -  Prior abdominal aortic aneurysm procedures

          -  Inability to visualize aneurysm on ultrasound

          -  Inability to provide consent

          -  Irregular arrhythmias

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 1-613-798-5555, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03993496

Organization ID

20190366-01H

Responsible Party

Principal Investigator

Study Sponsor

University of Ottawa

Study Sponsor

, ,

Verification Date

August 2019